At a Glance
- Tasks: Be the go-to QA expert in a sterile manufacturing environment, ensuring top-notch quality.
- Company: Join a leading life sciences manufacturer dedicated to innovation and excellence.
- Benefits: Gain valuable experience, competitive pay, and opportunities for professional growth.
- Why this job: Make a real difference in healthcare by ensuring the safety and quality of medicinal products.
- Qualifications: Life science degree and experience in aseptic pharmaceutical environments required.
- Other info: Dynamic role with a focus on teamwork and continuous improvement.
The predicted salary is between 36000 - 60000 Β£ per year.
Walker Cole International is supporting a regulated life sciences manufacturer in the appointment of a Quality Assurance Officer on a Fixed Term Contract within their Sterile Manufacturing Quality function. This role offers the opportunity to act as a key QA liaison in an aseptic manufacturing environment, supporting both marketed and investigational medicinal products.
Responsibilities:
- Acting as the primary QA point of contact for Sterile Manufacturing operations.
- Managing GMP deviations, quality incidents, OOS results, complaints, and CAPA activities.
- Performing batch record review, change control, SOP review, and New Product Introduction support.
- Planning and conducting internal audits, Gemba walks, training, and supporting client and regulatory audits.
Qualifications / Success Factors:
- A relevant life science-based degree or above.
- Experience in aseptic sterile pharmaceutical environments.
- Strong working knowledge of GMP, ISO 13485, EU GMP (EudraLex Volume 4), and FDA 21 CFR.
- A proactive, detail-focused approach with strong communication and stakeholder engagement skills.
Quality Assurance Officer employer: Walker Cole International
Contact Detail:
Walker Cole International Recruiting Team
StudySmarter Expert Advice π€«
We think this is how you could land Quality Assurance Officer
β¨Tip Number 1
Network like a pro! Reach out to professionals in the life sciences sector, especially those in quality assurance. LinkedIn is a great place to start β connect with people, join relevant groups, and engage in discussions. You never know who might have the inside scoop on job openings!
β¨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GMP and ISO standards. Make sure you can discuss how you've handled quality incidents or CAPA activities in the past. We want you to showcase your experience and how it aligns with the role of a Quality Assurance Officer.
β¨Tip Number 3
Donβt just apply anywhere β focus on companies that align with your values and career goals. Check out our website for opportunities at Walker Cole International and tailor your applications to highlight your relevant skills in aseptic manufacturing and regulatory compliance.
β¨Tip Number 4
Follow up after interviews! A quick thank-you email can go a long way in leaving a positive impression. Use this opportunity to reiterate your enthusiasm for the role and mention any key points from the interview that you feel strongly about.
We think you need these skills to ace Quality Assurance Officer
Some tips for your application π«‘
Tailor Your CV: Make sure your CV highlights your experience in aseptic sterile pharmaceutical environments and your knowledge of GMP and ISO standards. We want to see how your background aligns with the Quality Assurance Officer role, so donβt hold back on showcasing relevant skills!
Craft a Compelling Cover Letter: Your cover letter is your chance to shine! Use it to explain why youβre passionate about quality assurance and how your proactive approach can benefit our team. Remember, we love a good story, so share your journey in the life sciences field.
Showcase Your Communication Skills: As a QA Officer, strong communication is key. In your application, highlight instances where you've effectively engaged with stakeholders or led training sessions. We want to see that you can be the primary QA point of contact with confidence!
Apply Through Our Website: We encourage you to apply directly through our website for a smoother process. Itβs the best way for us to receive your application and ensures you donβt miss out on any important updates. Letβs get your application rolling!
How to prepare for a job interview at Walker Cole International
β¨Know Your GMP Inside Out
Make sure you brush up on your knowledge of Good Manufacturing Practice (GMP) and relevant regulations like ISO 13485 and FDA 21 CFR. Being able to discuss these in detail will show that you're not just familiar with the terms, but that you understand their practical application in a sterile manufacturing environment.
β¨Prepare for Scenario Questions
Expect questions about how you would handle GMP deviations or quality incidents. Think of specific examples from your past experience where you successfully managed similar situations. This will demonstrate your proactive approach and problem-solving skills.
β¨Showcase Your Communication Skills
As a QA Officer, you'll need to engage with various stakeholders. Be ready to discuss how you've effectively communicated complex information in previous roles. Practising clear and concise explanations will help you convey your ideas confidently during the interview.
β¨Familiarise Yourself with Internal Audits
Since planning and conducting internal audits is part of the role, be prepared to talk about your experience with audits and Gemba walks. Highlight any specific methodologies youβve used and how they contributed to improving quality standards in your previous positions.